Wet injection detection and prevention system and method

ABSTRACT

In an embodiment, a medicament delivery system is provided. The medicament delivery system includes a container for storing a medicament prior to use, the container having a first end and a second end, an injection member in fluid communication with the container, an actuation mechanism associated with the container and configured to deliver the medicament from the container through the injection member when the actuation mechanism is activated. The medicament delivery system further includes at least one detection element associated with the system, wherein in a first mode of operation of the system, medicament is delivered through the injection member and in a second mode of operation of the system, medicament is not delivered through the injection member, and the mode of operation is dependent on an output from the at least one detection element.

BACKGROUND

Manual disposable syringe based devices have existed since themid-1800's. These devices were designed for a single purpose ofperforming a subcutaneous injection through a hollow-bore needle affixedto the syringe device. Syringes are simple mechanical systems with nocapability of refined fluid dynamics or ability to integrate advanceddigital capabilities.

A prefilled syringe is a primary drug container and delivery system forthe administration of an injectable therapy by a healthcare worker or apatient. Prefilled syringes are typically supplied to pharmaceuticalcustomers in a ready-to-fill format for filling and packaging with ameasured dose of an injectable drug or vaccine. The primary container iscompliant with industry standards and pharmacopeias to ensure protectionof the drug formulation over a prolonged duration.

Auto-injectors are used for self-administration by the patient outsideof the healthcare system. Auto-injectors are designed to allow operatorsto automatically deliver the contents of a prefilled syringe at the pushof a button. The auto-injector market is one of the fastest-growingsegments in the medical device market. Auto-injection or “pen” deviceshave recently become increasingly popular for single dose or multi dose,at home self-administration. These auto-injection devices are primarilydesigned to accomplish two basic objectives: convenience and automationof drug delivery in an outpatient setting. These are typicallymechanically spring-loaded devices that advance a component of thedevice to transfer medication via hollow-bore needle to a patient'stissues.

Auto-injection devices are routinely used to provide a means forself-injecting certain medications. The size and operation of theseauto-injection devices can often be daunting to a patient, whether theyare injecting themselves for the first or they have injected themselvesbefore. These fears and anxieties associated with the currentlyavailable self-injection devices, particularly the auto-injectiondevices, may result in the administration of an incomplete dose of amedicament, failure to administer any portion of the dose of amedicament, or accidentally sticking oneself with the needle of thedevice, which in some instances could lead to unwanted transmission ofdiseases if the needle is contaminated. Furthermore, oftentimesmedications are wasted when an injection device is removed from thepatient mid-way through an injection before an entire dose of medicamenthas been received by the patient. As a result, reduced therapycompliance is also a great concern with injection devices.

Auto-injection devices lack the ability to regulate whether themedication is actually delivered to the patient or whether it isdelivered to a correct location. Most auto-injection devices fail tointegrate advanced digital capabilities. Therefore, there exists a needfor an injection device which may be safely and efficiently used bypatients without medical experience in preparing and self-injectingmedications and which increases therapy compliance.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description briefly stated above will be rendered byreference to specific embodiments thereof that are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments and are not therefore to be considered to be limiting of itsscope, the embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 provides a cross sectional view of an embodiment of a medicamentdelivery system.

FIG. 2 provides a cross sectional view of another embodiment of amedicament delivery system.

FIG. 3 provides a cross sectional view of a further embodiment of amedicament delivery system.

FIGS. 4A-4B provide a cross sectional view of another embodiment of amedicament delivery system in a first mode of operation, and a secondmode of operation, respectively.

FIG. 5 provides an exploded view of an embodiment of a container.

FIG. 6 provides an exploded view of another embodiment of a container.

FIG. 7 is a cross sectional view of an embodiment of a medicamentdelivery system in use, wherein an injection member is in a targettissue of a patient during an injection.

FIG. 8 is a cross sectional view of the embodiment of the medicamentdelivery system of FIG. 7, wherein the medicament delivery system hasbeen moved such that the injection member has been removed from thetissue of the patient during the injection.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles andoperation of the invention, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated device, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to thoseskilled in the art to which the invention pertains.

Definitions

A “predetermined value” as used herein, for example, includes but is notlimited to a value or range of values relating to an event involving useor operation of the device. These may include, but are not limited tothresholds, ceilings, baselines or range values that are desired orundesired for a particular event. Examples of predetermined valuesinclude, but are not limited to, a predetermined temperature value,predetermined time value, or a predetermined contact value, in additionto other predetermined values described herein refers to a value that isused as a reference value in relation to a value, signal, or indicationthat is detected by, for example, a detection element of the medicamentdelivery system. Predetermined value may include an optimal value, or asub-optimal value, or any value there between. In one example, apredetermined time value may include 1 minute for resetting the system,an additional predetermined time value may include 10 seconds forresetting the system.

The term “associated” or “association”, as used herein, includes but isnot limited to direct and indirect attachment, adjacent to, in contactwith, partially or fully attached to, and/or in close proximitytherewith. The term “value” as used herein, may refer to a specificvalue or a range of values.

It is to be noted that the terms “first,” “second,” and the like as usedherein do not denote any order, quantity, or importance, but rather areused to distinguish one element from another. The terms “a” and “an” donot denote a limitation of quantity, but rather denote the presence ofat least one of the referenced item. The modifier “about” used inconnection with a quantity is inclusive of the stated value and has themeaning dictated by the context. It is to be noted that all rangesdisclosed within this specification are inclusive and are independentlycombinable. Furthermore, to the extent that the terms “including,”“includes,” “having,” “has,” “with,” or variants thereof are used ineither the detailed description and/or the claims, such terms areintended to be inclusive in a manner similar to the term “comprising.”

Notwithstanding that the numerical ranges and parameters setting forththe broad scope are approximations, the numerical values set forth inspecific non-limiting examples are reported as precisely as possible.Any numerical value, however, inherently contains certain errorsnecessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all sub-ranges subsumedtherein. As a non-limiting example, a range of “less than 10” caninclude any and all sub-ranges between (and including) the minimum valueof zero and the maximum value of 10, that is, any and all sub-rangeshaving a minimum value of equal to or greater than zero and a maximumvalue of equal to or less than 10, e.g., 1 to 7.

The term “injection member” as used herein includes a needle or othermember used to traverse the skin of a user and inject fluid therethrough, in one example. Various actuation mechanisms can be used toactuate the system as described herein; however, in order to effect aslow and controlled movement, a solenoid or a motorized actuationmechanism can be used, for example. However, this is not intended to belimiting, for example, “solenoid” includes, but is not limited to, asolenoid with a solenoid shaft that may interact with a plunger orstopper when it is activated, for example. Different types of actuationmechanisms known in the art and other actuation mechanisms describedherein may also be used, including but not limited to ACME/lead screws,springs, compressed air, magnetic, flexinol/muscle wire, solenoids,standard DC motors, pancake motors, other motors, peristaltic pumps(s),and any other related actuation mechanisms. Actuation members asdescribed herein refer to components of the system used to initiateactuation of the actuation mechanism(s). Examples of actuation membersinclude, but are not limited to buttons, switches, and any other typesof actuation members known to those of skill in the art.

The inventors have discovered several areas in which the prior art couldbe improved. Prior art injection devices and syringes have been found tolack safety and features and convenient as well as cost-saving andtherapy compliance features. Oftentimes during an injection, the needleis removed from the patient before the injection is complete (or theinjection is actuated before the needle is in the patient) and beforethe entire dose of medicament is received by the patient resulting indecreased medication therapy compliance as well as increased medicationand economic waste. Therefore, the inventors herein have identified amedicament delivery system and method which solves many of these issuesfound in the prior art.

The subject invention includes, in one embodiment, a medicament deliverysystem, wherein the system includes a container for storing a medicamentprior to use. The container includes a first end and a second end, aninjection member in fluid communication with the container, an actuationmechanism associated with the container and configured to deliver themedicament from the container through the injection member when theactuation mechanism is activated, and at least one detection elementassociated with the system. Wherein in a first mode of operation of thesystem, medicament is delivered through the injection member and in asecond mode of operation of the system, medicament is not deliveredthrough the injection member, and the mode of operation is dependent onan output from the at least one detection element.

In a further embodiment, the system may include a controller configuredto monitor the output from the at least one detection element, thecontroller configured to operate the system in one of the first mode ofoperation or the second mode of operation in response to the outputreceived. Based on output generated by the at least one detectionelement, activation and/or inactivation of the actuation mechanism canbe electronically controlled by the controller, in an embodiment.

In still a further embodiment, the system may include a stopper, whereinthe stopper interacts with the actuation mechanism such that when theactuation mechanism is activated, the stopper traverses the containerfrom a first position of the stopper to a second position of the stoppersuch that medicament is delivered through the injection member as thestopper moves from the first position to the second position. In thefirst position of the stopper, the injection has not yet begun and nomedicament has been delivered into or through the injection member. Inthe second position of the stopper, the medicament dose has beencompletely delivered from the container through the injection member. Atany point between the first position and the second position of thestopper, the delivery of medicament may be incomplete. In a single doseembodiment of the system, wherein the entire medicament contents of thecontainer is equivalent to one dose of medicament, the second positionof the stopper is at a bottom of the container. In a multi-doseembodiment of the system, wherein the container includes multiplecomplete doses of medicament, the second position of the stopper is at apredetermined position between the top and the bottom of the container.At this intermediate location in a multi-dose container, a full dose ofmedicament is provided.

The system may further include at least a first sensing element. Thefirst sensing element can sense and provide an output based on theposition of the stopper relative to the container or relative to anobject outside the system. In a further embodiment, the system comprisesa second sensing element. The second sensing element may be associatedwith the stopper such that it can sense a position of the first sensingelement, or the first sensing element can sense the position of thesecond sensing element, such that the position of the stopper can besensed and an amount of medicament delivered through the injectionmember can be sensed. In another embodiment, the at least a first orsecond sensing element of the system can sense and provide an outputbased on the position of the stopper relative to a housing within whichthe container is supported. In one particular embodiment, the secondsensing element may include one or more magnets, in a non-limitingexample, and the first sensing element may sense the one or moremagnets. Such that in a non-limiting embodiment, if the second sensingelement is associated with the stopper and the first sensing element isassociated with the container housing (i.e., first housing or secondhousing) or a housing configured to receive the container, or an objectoutside the system, movement of the stopper relative to first sensingelement will be detected by the first sensing element. Therefore, thelocation of the stopper can be sensed and thus, an amount of medicamentdelivered and/or remaining can be determined. In another non-limitingexample, the first or second sensing element may include a LinearVariable Differential Transformer (LVDT), which can sense displacementof the stopper, the container and/or the injection member, for example.

In an alternative embodiment, a medicament delivery system is providedwherein the system includes a container for storing a medicament priorto use. The container includes a first end and a second end, aninjection member in fluid communication with the container, an actuationmechanism associated with the container and configured to deliver themedicament from the container through the injection member when theactuation mechanism is activated, and a timer component. The system mayinclude a controller, wherein the timer component may be a component ofthe controller. The timer component may detect, record, or combinationthereof, events that occur with the medicament delivery system, forexample, the timer component may detect a time when actuation of thesystem begins, the time at which medicament delivery through theinjection member begins, the time at which the is delivered from thecontainer, the time when the actuation mechanism is activated, and/orthe time when the actuation member is inactivated, for example, innon-limiting embodiments. This time detected and/or recorded may becompared to a predetermined time of movement of the actuation mechanismto complete delivery of medicament, or to a predetermined time ofmovement of the stopper relative to the second housing of the containerto complete delivery of medicament therefrom, for example In oneembodiment, the system may detect a wet injection if the time detectedfrom actuation of the system to the time the stopper ceases movement isless than the time predetermined and stored in the system for completionof an injection from actuation of the system to the time the stopperceases movement when an injection has been fully delivered to a patient.According to this embodiment, a separate detection element is notnecessary to monitor for a wet injection event.

In a first mode of operation of the system, medicament is deliveredthrough the injection member and in a second mode of operation of thesystem, medicament is not delivered through the injection member, andthe mode of operation is dependent on an output from the at least onedetection element.

In a further embodiment, the system may include a controller configuredto monitor the output from the at least one detection element, thecontroller configured to operate the system in one of the first mode ofoperation or the second mode of operation in response to the outputreceived. Based on output generated by the at least one detectionelement, activation and/or inactivation of the actuation mechanism canbe electronically controlled by the controller, in an embodiment.

In a further embodiment, a medicament delivery system is provided,wherein the system includes a container for storing a medicament priorto use. The container includes a first housing for containing amedicament, a stopper associated with the first housing, a secondhousing within which the first housing is encased, an injection memberassociated with a lower portion of the first housing and movable throughan injection opening in the first housing, and a spring disposed betweenthe first housing and the second housing. The system further includes aat least one detection element associated with the container and providean output based on a condition detected by the at least one detectionelement, an actuation mechanism associated with the system such thatwhen the actuation mechanism is activated, the first housing movesrelative to the second housing in a first direction, the spring isbiased, the injection member is extended from the second housing, thestopper moves relative to the first housing to deliver medicamentthrough the injection member, such that when the first housing movesrelative to the second housing in a second direction, the spring isreleased and the injection member is retracted into the second housingto prevent an unintentional contact with the injection member. In afirst mode of operation of the system, the medicament is deliveredthrough the injection member and in a second mode of operation of thesystem, the medicament is not delivered through the injection member,and the mode of operation is dependent on the output generated by the atleast one detection element.

The at least one detection element may be provided on any portion orassociated with any portion of the system, including but not limited toa lower portion of the container, or a portion of a housing of thesystem, a portion of the injection member, the actuation mechanism, thestopper, an inner surface of the container or an outer surface of thecontainer, in non-limiting examples.

In a further embodiment, the at least one detection element comprises acontact sensor, wherein the output generated by the at least onedetection element is dependent on whether a contact is made between thecontact sensor and a patient. The contact sensor may be provided on alower portion of the container such that removal of the container fromthe user signals no contact signal to the processor. In anothernon-limiting embodiment, the contact sensor may be placed on a housingcontaining the container or on a portion of the injection member or onthe stopper. The contact sensor enables the system to detect if thecontainer or the system has been removed from a target injection site ofthe patient during an injection in order to prevent or minimize a wetinjection. In general terms, sensors may be associated with thecontainer or the system, and may indicate or detect an amount ofmedicament in the container. Specific, non-limiting examples andembodiments of sensors used to make these determinations are describedmore fully herein.

A wet injection can include instances in which the injection member isremoved from the patient while an injection is in progress (i.e.,medicament flows through the injection member once the injection memberis removed from the patient's body), therefore wasting medicament andpreventing the patient from receiving the proper dose of medicament.Other cases of wet injections occur before the injection member isinserted into the patient and before an injection has begun, wherein thesystem is activated and medicament is delivered through the injectionmember into the environment. In an embodiment, when the system is in asecond mode of operation and the stopper is disposed between the firstposition and the second position, an output is generated by a sensingelement indicating that an incomplete delivery of medicament hasoccurred (i.e., a wet injection has been detected). Therefore, inembodiments herein, one or more sensing elements can sense the locationof various parts of the system relative to various other parts, forexample as described herein, in a non-limiting example, a first sensingelement associated with a first or second housing of the container cansense a location or position of a second sensing element associated withthe stopper. This information can be used to identify an amount ofmedicament remaining in the container or delivered from the container.In another embodiment, if the injection member has been removed from thepatient, and the stopper is in motion, the system may detect a wetinjection has occurred or is going to occur and delivery of medicamentfrom the container is halted.

In one embodiment, the at least one detection element is associated withthe injection member, wherein the at least one detection elementincludes a sensor, and the sensor is configured to detect a differencebetween the pressure of air and pressure of skin of a patient (e.g., apressure sensor) to detect whether the injection member has beeninjected into the patient. An output is generated by the sensor toindicate to the system to stop activation of the actuation member orstop movement of the stopper or to prevent the flow of medicamentthrough the injection member in any of the methods described herein toprevent a wet injection if the at least one detection element detectsthat the injection member is not in the patient and the actuation memberhas been activated.

In another embodiment of the system, the medicament delivery systemincludes a flow of electricity through the injection member such thatwhen a change in an electrical property is detected the second mode ofoperation is initiated. In a further embodiment, a change in a unit ofmeasurement on the injection member is detected by the detection elementas the injection member is inserted into or removed from a patient, andwherein the mode of operation is dependent on a value of the unit.Examples of electrical properties described herein include, but are notlimited to, electromagnetic properties, ultrasonic, sonar, andtemperature properties. In some instances the detection element may be acomponent of or associated with the injection member. In other instancesthe injection member may be the detection element. Therefore, theelectrical properties may be detected via the injection member innon-limiting embodiments.

In a further embodiment of the medicament delivery system, the at leastone detection element may include a light sensor. The output from the atleast one detection element may be dependent on whether a light beam isprojected from the container and detected by the light sensor in oneexample which could indicate that a wet injection has occurred or isabout to occur. In another example, projection of a light beam from thesystem may be visually identified by the user or patient of the systemto detect whether a wet injection may occur or is occurring. In still afurther embodiment, the system may be configured to stop or halt a flowof medicament if the light beam is projected from the system.

In yet a further embodiment, the at least one detection element mayinclude a temperature sensor which can identify or detect a temperatureof the skin of a patient or an internal temperature of a patient innon-limiting embodiments. The output of the at least one detectionelement may be dependent on a temperature detected by the temperaturesensor. In one particular embodiment, the system may operate in thefirst mode of operation when the temperature sensor detects atemperature of the patient between 87 and 100 degrees Fahrenheit. Inanother embodiment, the system may operate in the first mode ofoperation when the temperature sensor detects a temperature between 90degrees Fahrenheit and 93 degrees Fahrenheit. In still a furtherembodiment, the system may include a contact sensor and a temperaturesensor in which the mode of operation of the system is dependent on anoutput generated by the at least one detection element based on thecontact sensor and the temperature sensor. In a non-limiting example,the system may require that contact be detected by the contact sensorand that a temperature of a particular degree range be detected by thetemperature sensor to detect that the system is in contact with apatient and not an inanimate object, for example, in order to prevent awet injection.

In still a further embodiment, the at least one detection elementincludes a proximity sensor to detect a proximity of the system to atarget area of a patient. The mode of operation of the system may dependon the output generated by the at least one detection element based onthe proximity of the system to the target area. The target area of apatient may include an intended injection area and areas adjacent to theintended injection area. The target area of a patient may depend on thetype of medicament being injected, for example. The target area of thepatient may change from one injection to the next based on the need tomove injection sites in instances where many injections are beingperformed in one general area of a patient in order to reduce traumaand/or pain to that particular area, for example.

The container may include an electrical current directed therethrough inorder to detect an amount of medicament therein, in an embodiment. Thisis useful, for example, wherein a wet injection occurs and is detectedby the system, and an amount of medicament remaining in the containerneeds to be measured to determine how much medicament was delivered tothe patient and how much of the complete dose remains. In someembodiments, once a wet injection is detected, the user must replace thecontainer of the system with a new container and/or a new needle tocomplete the dose of the medicament. The identification of the amount ofmedicament remaining in the container is therefore very helpful indetermining the amount of medicament required to complete the requireddose. The system then identifies an amount of the medicament in the newcontainer required to be injected to complete the dose.

In another embodiment, the system may include one or more valves. Theone or more valves may be configured to open and close in response tooutput generated by the at least one detection element. In one instance,when the valve is open, medicament is delivered through the injectionmember, and when the valve is closed, delivery of medicament through theinjection member is halted.

The injection member may be associated with the container such that itis extended from the container upon activation of the actuationmechanism, and retracted into the container after use. It iscontemplated herein that a number of different variations of retractionmechanisms can be used. For example, a tension spring can be associatedwith a second housing of the system (described in a further embodimentdiscussed below) and a portion of the first housing, wherein the springcould be used to move the first housing relative to the second housingin a second direction to retract the injection member. Anotherembodiment may include an actuation mechanism which attaches onto orassociates with the stopper or the first housing so as to retract thefirst housing. Retraction of the injection member serves to provide asafety mechanism to prevent a user from sticking themselves with theinjection member before, during, or after an injection event. In anembodiment, the retraction may occur if the injection mechanism isextended from the container before the injection or delivery ofmedicament has begun, during an injection if the injection member isremoved from the patient, and/or after an injection has been completed.

In some embodiments described herein, the injection member is extendedfrom the container when the actuation mechanism is activated and thesystem is in a first mode of operation, and the injection member isretracted into the container when the system is in a second mode ofoperation.

In a further embodiment of the system, an obstruction member isprovided, wherein upon retraction of the injection member into thecontainer the obstruction member obstructs (blocks or covers over) theinjection opening such that extension of the injection member therethrough is prevented. This is a safety feature to prevent unwantedsticks of the user with the injection member.

In still a further embodiment, a locking mechanism is associated withthe actuation mechanism, wherein the locking mechanism is initiated(initiation of the locking mechanism may include locking or unlocking ofthe locking mechanism, depending on the output received) in response tothe output generated by the at least one detection element. When thelocking mechanism is in a locked position, delivery of medicamentthrough the injection member is prevented, and when the lockingmechanism is in an unlocked position, medicament is delivered throughthe injection member. The locking mechanism controls initiation of thedelivery of medicament, i.e., whether the system will enter a secondmode of operation.

In yet a further embodiment, the system includes a stopping mechanism,wherein the stopping mechanism may be activated in response to an outputgenerated by the at least one detection element and in a furtherembodiment, the at least one detection element and the at least onesensing element, wherein the stopping mechanism is configured to haltdelivery of the medicament after the actuation mechanism has beenactivated and before delivery of the medicament is complete. In anembodiment, delivery of the medicament is complete when a full dose hasbeen delivered through the injection member. The system may be adaptedfor use with either or both of single-dose and multi-dose injections.While in single-dose injections, the container is empty once the fulldose has been delivered, however, in multi-dose injections, thecontainer may contain other subsequent doses of medicament even after afull dose has been delivered through the injection member. The variousways in which the stopping mechanism functions include, but are notlimited to, stopping a motor of the system, stopping a spring in thesystem or other component of the system from functioning or moving byway of a brake, and numerous other mechanical and electrical ways ofstopping the delivery of medicament from the container as are known tothose of skill in the art.

In an embodiment, a motor is configured to drive the system. Theprocessor may be associated with the stopper and the motor associatedwith either the first housing and/or the stopper, such that when thedetection element detects no contact between the patient and thedetection element, the processor stops the motor from moving the firsthousing in a first direction relative to the second housing and/or thestopper in a first direction relative to the first housing to preventthe medicament from being delivered through the injection member. Inaddition to, or in place of a detection element used to detect contactor lack thereof between the user and the container or system, othermeans to detect contact known in the art are contemplated hereinincluding, but not limited to contact sensors or contact switches. In afurther embodiment, as discussed herein, at least a first sensingelement and a second sensing element can be used to detect an amount ofmedicament remaining in the container, whereby an output may begenerated by the first or second sensing element, such that the mode ofoperation of the system is dependent on the output. The mode ofoperation of the system may be dependent on both an output from thedetection element and an output from one or more sensing elements of thesystem in an embodiment. Consequently, both injection member location(relative to the patient) as well as amount of medicament in thecontainer can be detected or sensed and as a result, the mode ofoperation of the system can be determined, in an embodiment.

In another embodiment, the system may further include a flow ofelectricity through the injection member such that when a change in anelectrical property is detected the second mode of operation isinitiated. Examples of electrical properties described herein include,but are not limited to, electromagnetic properties, ultrasonic, sonar,and temperature properties. In a further embodiment, a change in a unitof measurement on the injection member may be detected as the injectionmember is inserted into or removed from the patient. The mode ofoperation of the system may be dependent on a value of the unit ofmeasurement detected.

Once a wet injection has been detected, the system providesrehabilitative processes in an embodiment. The amount of medicamentremaining to complete a dose of medicament can be identified. An amountof medicament remaining in the container may be identified based on theamount of displacement of the stopper within the container after a wetinjection is detected in one embodiment, and as described herein, thiscan be sensed with the first and second sensing elements or by othermeans described herein. In another embodiment, when the system is in asecond mode of operation and the stopper is between the first positionand the second position, a number of turns of the motor may indicate anamount of medicament remaining in the container. The motor can beactuated in a number of manners including activation by the actuationmechanism, by contact with a user, with a button or switch, orautomatically following a series of steps, or by any other means knownto those of skill in the art.

In another embodiment, the system may include a flow sensor in order todetect the amount of medicament delivered through the injection member,and may therefore provide information relating to the amount ofmedicament remaining in the container. The flow sensor may be providedin the injection member, adjacent to the injection member, or in thecontainer in non-limiting examples. In still a further embodiment, theamount of medicament remaining in the container can be identified with avisual indicator of the system. The visual indicator may include awindow provided to allow a user to view the amount of medicamentremaining or the position of the stopper, for example. In anotherembodiment, the visual indicator includes a series of lines orindications on the container, lights or a screen associated with thesystem, or a change in color of at least a portion of the system orcontainer in order to indicate the amount of medicament remaining in thecontainer or that the medicament dose has been completely delivered fromthe container.

Once the system is in the second mode of operation, in an embodiment, itis automatically reset or is configured to be manually reset such thatany remaining medicament in the container can be delivered through theinjection member, in an embodiment. Reset may include, but is notlimited to, the unlocking of the locking mechanism, inactivation of thestopping mechanism, in non-limiting examples. In one particular example,the locking mechanism can automatically reset to the unlocked positionfollowing a predetermined time period. This predetermined time periodmay be set by the user of the system prior to using the system, or maybe preset by the manufacturer of the system, for example. Thepredetermined time period may range between one (1) second and ten (10)minutes in one embodiment, or between five (5) seconds and five (5)minutes in a further embodiment.

In another embodiment, following the second mode of operation, thesystem can be configured for reset wherein the container may be replacedwith a new container for purposes of completing a dose of medicament, orin order to begin a new medicament dose. In yet another embodiment, thesystem may be reset to begin the first mode of operation upon activationof the actuation mechanism or upon insertion of a container, in nonlimiting examples. The reset of the system may be automatic or manual.

In yet a further embodiment, the system described herein can beactivated by a peristaltic pump actuation mechanism by which themedicament can be contained within a flexible container, and a rollerattached to a rotor which compresses the flexible container so as todisplace the medicament from the container such that it is deliveredthrough the injection member. As the rotor turns, the part of thecontainer under compression is occluded by the roller and the medicamentwithin the container is forced to be pumped to move through the tube andthrough the injection member. Once the container is opened to itsnatural state, fluid flow is induced to the pump. In some embodiments,two or more rollers may occlude the container and trapping a body ofmedicament between them. The medicament can then be transported towardthe pump outlet, in one example.

The detection element described herein may be integrated into,associated with, adjacent to, or on the injection member in certainembodiments.

In an embodiment, a method for preventing a wet injection from occurringduring a patient injection with a medicament delivery system comprisingan injection member and a first container containing a medicament doseis provided. The method includes sensing an amount of medicament in thecontainer, such that an incomplete dose of medicament can be detected,detecting a removal of the injection member from the patient when amedicament dose is incomplete, halting a flow of the medicament throughthe injection member when the injection member is removed from thepatient and the medicament dose is incomplete, and providing anindication to the patient to rehabilitate the system to complete themedicament dose.

In a further embodiment, the removal of the injection member form thepatient can be detected via a visual observation, one or more sensors, achange in an electromagnetic property, or one or more switches. In anembodiment, the flow of medicament through the injection member ishalted via one or more valves, a brake, or an electrical stop signal.

In a further embodiment, an indication to the patient to rehabilitatethe system comprises a series of stepwise instructions audibly providedto the patient by the system. The stepwise instructions may be providedvia a speaker associated with the system. In another embodiment, theindication to the patient to rehabilitate the system comprises one ormore visual indications to the patient. Visual indications may beprovided as described herein, including but not limited to a light orseries of light indicators, a window providing a view into the system orcontainer such that a user can identify the amount of medicamentremaining or delivered, or a screen or display providing informationregarding the amount of medicament remaining or delivered from thecontainer, for example.

In a further embodiment, the indication to the patient to rehabilitatethe system comprises an indication to replace the first container with asecond container and activate the system to inject a calculatedmedicament dose amount substantially equivalent to the medicament doseremaining in the first container. In another embodiment, therehabilitation of the system to complete the medicament dose comprisesproviding an indication to the patient to re-insert the injection memberinto the patient and activate the system to complete the medicament doseremaining in the container. In yet another embodiment, therehabilitation of the system to complete the medicament dose comprisesreplacing the injection member and providing an indication to thepatient to insert the injection member into the patient and activate thesystem to complete the dose remaining in the container.

In still another embodiment, a medicament delivery system as describedin embodiments herein is provided, wherein based on the output generatedby the detection element, information about the detection is provided tothe system, and the medicament continues to be delivered through theinjection member. For example, if a wet injection is detected, thesystem is notified, but the injection continues in one non-limitingembodiment.

For example, in a non-limiting embodiment, a medicament delivery systemis provided including a container for storing a medicament prior to use,the container having a first end and a second end. An injection memberis in fluid communication with the container, an actuation mechanismbeing associated with the container and configured to deliver themedicament from the container through the injection member when theactuation mechanism is activated, and at least one detection element isassociated with the system, wherein the at least one detection elementis configured to detect when the injection member is removed from apatient during medicament delivery through the injection member.

Turning to the drawings, FIG. 1 provides a cross sectional view of anembodiment of the medicament delivery system 10, including an actuationmember 16 which activates the system 10, a speaker 24, a controller 22and housing a container 12. The medicament delivery system 10 is in afirst mode of operation and an injection member 14 is delivered from thecontainer 12. A first spring 32 and a second spring 34 are biased toallow delivery of the injection member 14 from the container 12 and toprovide movement of the stopper 26 in a first direction relative to thesecond housing 28 to deliver medicament within the container 12 throughthe injection member 14 based on output provided to the controller 22from the detection element (i.e., contact sensor 20 a) on the housing11. The detection element 20 may generally include an electromechanicalelement, in an embodiment. Interconnection between the actuationmechanism(s) 17, actuation member(s) 16, controller (22) and othervarious parts of the system along with the connectivity there betweenare as described in U.S. patent application Ser. Nos. 61/788,033,14/017,933, and 61/886,596. One skilled in the art would understand theinterconnectivity and function between the motor, controller, actuationmechanism and other parts of the system in view of the teachings ofthese applications. One skilled in the art would also understand thatcommunications between the components of the system, including thedetection elements, the actuation members, the controller, for example,can occur wirelessly or through a wired connection as known in the art.The stopper 26 is shown in a second position within the container 12. Adetection element 20 is provided on a lower portion of the housing 11 ofthe system 10. In this embodiment, the detection element includes acontact sensor 20 a, but in other embodiments may include a light sensor20 b (as shown in FIG. 2), or a temperature switch 20 c (as shown inFIG. 3), in non limiting examples.

A brake (33) is provided in the system 10 of FIG. 1, wherein based onthe output received from the detection element 20, the brake 33 may beinitiated to halt movement of the stopper, and therefore prevent furtherdelivery of medicament through the injection member 14. This occurs, forexample, when a wet injection is detected by the system in order toprevent delivery of medicament from the system when the injection memberis not inserted into the user, in one embodiment. Therefore, when a wetinjection is detected via the detection element 20, the brake 33 engagesthe shaft of the stopper 26, preventing movement of the stopper 26relative to the second housing 28 to prevent medicament from flowingthrough the injection member 14.

FIG. 2 shows a cross section of another embodiment of the system 10having a housing 11 and an actuation mechanism 17 which can be activatedby the actuation member 16. The actuation mechanism 17 in the embodimentprovided in FIG. 2 shows a motor and a drive shaft component which drivethe movement of the stopper 26 relative to the container 12 to controlmovement of the stopper 26 relative to the second housing 28 andmovement of the second housing 28 relative to the first housing 30, orvice versa.

FIG. 2 provides a detection element embodied as a light sensor 20 b. Thelight sensor 20 b can detect light emanating from a light source 46 whenthe container and/or the housing 11 is not in contact with the user.When the housing 11 is in contact with a target surface of a user, lightemanating from the light source 46 is obstructed, and not detected bythe light sensor 20 b. The light source 46 is shown as in contact with abottom surface of the housing 11; however, the light source may beprovided within or disposed on a portion of the container 12 such thatwhen a lower surface of the housing 11 is not in contact with a surfaceof a user, light may emanate from the light source 46, in an embodiment.In another non-limiting embodiment, the light sensor 20 b may detect areflection of light from the light source 46 off of a surface of a userwhen the housing 11 is not in contact with the surface of the user. Inresponse to detection of light by the light sensor 20 b, an output isgenerated to the system 10 to detect, or to detect and prevent or haltdelivery of medicament through the injection member 14 to detect ordetect and prevent a wet injection. FIG. 2 includes a locking mechanism47, wherein the locking mechanism prevents delivery of medicamentthrough the injection member when the locking mechanism 47 is in alocked position. This prevention is in response to an output generatedby the at least one detection element, e.g., the light sensor 20 b, forexample. Consequently, if the housing 11 is not against a surface of auser in position for injection, a light emanating from the light source46 is detected by the light sensor 20 b, and the locking mechanism 47remains in a locked position so as to prevent delivery of medicamentthrough the injection member (i.e., maintains the system 10 in a secondmode of operation).

FIG. 2 includes a locking mechanism 47, wherein the locking mechanismprevents delivery of medicament through the injection member when thelocking mechanism 47 is in a locked position. This prevention is inresponse to an output generated by the at least one detection element,e.g., the light sensor 20 b. Consequently, in one non-limiting example,if the light sensor 20 b detects light emanating from light source 46and/or reflecting off of a surface from light source 46, the lockingmechanism 47 may remain in a locked position. \

FIG. 3 is a cross-sectional view of an embodiment of the system 10having a housing 11, and a container 12 there within. A controller 22and a speaker 24 are provided on the system 10, and an actuation member16 is associated with the system 10. The actuation member 16 is providedto activate the actuation mechanism 17 shown as including a motor and adrive shaft component which drive movement of the stopper 26 relative tothe container 12, for example. In the embodiment shown in FIG. 3, atemperature switch 20 c is disposed on a portion of the housing 11 so asto detect temperature of a surface that is associated with thetemperature switch 20 c. This is one non-limiting example of a method todetect at wet injection by detecting if the system 10 has been displacedfrom a surface of a user during an injection.

FIGS. 4A-4B illustrate the system 10 in a first mode of operation (FIG.4A) and second mode of operation (FIG. 4B), wherein medicament 18 is inthe container 12 of FIG. 4A, and the second spring 34 which drives thestopper 26 is unbiased. In the first mode of operation of the system 10medicament is delivered through the injection member 14 after activationof the system by way of the actuation member 16 as shown in FIG. 4A. Thesecond spring 34 includes a greater resistance than the first spring 32,in a non-limiting embodiment, such that by activating the actuationmember 16, the first spring 32 is compressed before the second spring 34and the injection member 14 traverses the first contaminant barrier 29(shown in FIG. 5) in the first housing 30 before the medicament 18 isdelivered from the injection member 14. The system 10 can compensate fordifferent forces required to inject for delivery of a medicament 18using the system 10. In one example, one force may be needed to force aneedle to puncture the skin of a user with the system 10, whereinanother force may be needed to disperse/deliver a medicament 18 from thesystem to a user. The subject invention can vary to compensate for thesedifferent forces. In one embodiment, springs of varying resistances maybe used. Based on an output generated by the detection element (i.e.,contact sensor 20 d), the system 10 may transition to the second mode ofoperation wherein no medicament is delivered through the injectionmember 14 in order to prevent a wet injection, and in certainembodiments, the injection member 14 is retracted into the first housing30 to prevent unintentional contact with the injection member 14 asshown in FIG. 4B.

In some embodiments, the wet injection detection and prevention isbased, in part, on the detection by the detection element 20 and in parton a first and second sensing element. FIGS. 4A-B provide a firstsensing element 36 as being disposed on a portion of the system 10, anda second sensing element 38 as associated with the stopper 26 such thatthe position of the stopper 26 relative to the first sensing element 36can be identified as the first sensing element 36 senses the position ofthe second sensing element 38 relative to the first sensing element. Innon-limiting embodiments the second sensing element 38 may be formed aspart of the stopper or embedded in the stopper. The first sensingelement 36 can generate an output to the system 10 or to the userincluding information about the position of the second sensing element38, or vice versa, in non-limiting embodiments. This information isuseful in determining an amount of medicament 18 that has been deliveredthrough the injection member 14 in order to determine whether a full orpartial dose has been given, and determine an amount of the doseremaining to be given to the user.

In the embodiment shown in FIGS. 4A-B, when the contact sensor 20 d ofthe system 10 detects that contact has been removed between the user andthe contact sensor 20 d, an output can be sent from the contact sensor20 d (one example of the detection element 20) to the system. In anembodiment, when the first sensing element 36 senses a position of thesecond sensing element 38, the second element is associated with thestopper 26, and the stopper 26 is in a position between a first positionand a second position, and no contact between the contact sensor 20 duser is detected by the contact sensor 20 d, the system 10 can detectthat a wet injection has occurred, the injection can be stopped (i.e.,system in the second mode of operation) by one of the methods describedherein. Methods of stopping the injection include, but are not limitedto initiating the break 33 to stop movement of the stopper 26. Forexample, a signal can be initiated to activate the break which canprevent the stopper 26 from moving. In one non-limiting example, thebreak 33 could operate by engaging a portion of the stopper 26 (i.e.,the shaft) by grasping the shaft upon sensing a wet injection hasoccurred or is about to occur. There are various ways known in the artto stop or prevent continued delivery of medicament through theinjection member. Alternatively, one can stop delivery of medicament byceasing activation of the system 10. In other embodiments as depicted inFIGS. 2-3, once a wet injection has been detected, an output is sent tothe controller 22, which in turn provides an output to the actuationmechanism 17 to stop, for example, in embodiments which include a motoras part of the actuation mechanism 17.

FIGS. 5 and 6 provide exploded views of the container 12, illustratingthe locations of the first contaminant barrier 29, second contaminantbarrier 31 and third contaminant barrier 33 to seal the container 10 andmaintain sterility of the medicament 18 there within. FIG. 5 provides adetection element 20 embodied as a sensor adjacent to the injectionmember 14. The detection element 20 provides an output based on thelocation of the detection element 20 relative to a target area of auser. Based on output received from the detection element 20, the systemoperates in the first or second mode of operation. An embodiment of avisual indicator 40 is displayed on the second housing 28 in FIG. 6,such that a user can determine an amount of medicament 18 within thecontainer 12 by way of the visual indicator 40. Various embodiments ofvisual indicators 40 are further described herein.

FIGS. 7-8 provide cross-sectional views of stepwise use of an embodimentof the system 10 as described herein. FIGS. 7 and 8 provide a system 10embodiment having a controller 22, a speaker 24, an actuation member 16,an actuation mechanism 17, a container 12 having a first and secondhousing, 30, 28, a stopper 26, a first biasing member 32 disposedbetween the first and second housings 30, 28, a detection element(contact sensor 20 a) disposed on a portion of the housing 11 of thesystem 10 to detect contact between the contact sensor 20 a and asurface (i.e., a target surface 42 a of a target tissue 42 of a user).The sensing elements 36, 38 are provided to detect the position of thestopper 26 during use of the system 10 and can be used to detect anamount of medicament remaining in the container 12 during an injectionand particularly, if a wet injection is detected by the system 10.Detecting an amount of medicament remaining in the container 12following a wet injection can provide information as to an amount ofmedicament remaining to be provided to a user after a wet injection isdetected, or detected and prevented. FIG. 7 shows an obstruction member45 associated with a lower portion of the housing 11 of the system 10.The obstruction member 45 may be a sliding member, wherein it slides,for example, to cover the opening through which the injection member 14exits the container 12 in a non-limiting embodiment as shown in FIG. 7,to prevent unwanted sticks by way of contact with the injection member14 when the container 12 is removed from the housing 11. In FIG. 8, theinjection member 14 is shown as retracted into the container 12, and theobstruction member 45 covers over the injection opening to preventextension of the injection member 14 there through, and/or insertion ofan object in through the opening to contact the injection member 14. Inother non-limiting embodiments, a portion of the obstruction member 45may hinge from the housing to allow passage of the injection member 14there through. Other mechanisms for causing the obstruction member toclose FIG. 8 shows the system 10 being removed from the user such thatthe contact sensor 20 a is displaced from the target surface 42 a of thetarget tissue 42 of the patient, wherein a wet injection is detected andprevented by the system 10. Once the wet injection is detected, theinjection member 14 is retracted back into the container 12 so as toprevent an accidental sticking of the user with the injection member 14and/or to preserve the sterility of the injection member 14. This mayoccur by way of the biasing member 32. The first and second sensingelements 36, 38 can detect the position of one another so as to identifyan amount of medicament delivered to the user and/or an amount ofmedicament remaining in the container 12.

Following detection and prevention of a wet injection, the system 10 mayprovide instructions to the user to rehabilitate the system 10 in orderto complete the injection. This rehabilitation may include re-activatingthe system 10 by way of the actuation member 16 to re-inject the user atthe target surface 42 a of the target tissue 42 to complete theinjection and deliver the remaining portion of the medicament to theuser, in one embodiment. In another embodiment, rehabilitation mayinvolve removal of the partially used container 12 and replacement witha new container 12 for use to deliver the remaining portion ofmedicament, for example. A determination of the amount of medicamentremaining in the previous, partially used container 12 following the wetinjection is critical to rehabilitation and delivery of a remainingportion of medicament after inserting a new container 12 into the system10. In another non-limiting embodiment, following detection andprevention of a wet injection, the partially used container 12 may bereused to complete the injection; however, a user may need to replacethe used injection member 14 with a new injection member 14 prior tocompleting the injection, for example.

It should be borne in mind that all patents, patent applications, patentpublications, technical publications, scientific publications, and otherreferences referenced herein are hereby incorporated by reference inthis application in order to more fully describe the state of the art towhich the present invention pertains.

It is important to an understanding of the present invention to notethat all technical and scientific terms used herein, unless definedherein, are intended to have the same meaning as commonly understood byone of ordinary skill in the art. The techniques employed herein arealso those that are known to one of ordinary skill in the art, unlessstated otherwise. For purposes of more clearly facilitating anunderstanding the invention as disclosed and claimed herein, thefollowing definitions are provided.

While a number of embodiments of the present invention have been shownand described herein in the present context, such embodiments areprovided by way of example only, and not of limitation. Numerousvariations, changes and substitutions will occur to those of skill inthe art without materially departing from the invention herein. Forexample, the present invention need not be limited to best modedisclosed herein, since other applications can equally benefit from theteachings of the present invention. Also, in the claims,means-plus-function and step-plus-function clauses are intended to coverthe structures and acts, respectively, described herein as performingthe recited function and not only structural equivalents or actequivalents, but also equivalent structures or equivalent acts,respectively. Accordingly, all such modifications are intended to beincluded within the scope of this invention as defined in the followingclaims, in accordance with relevant law as to their interpretation.

What is claimed is: 1-40. (canceled)
 41. A medicament delivery system,comprising: a container for storing a medicament prior to use, thecontainer comprising; a first housing for containing a medicament; astopper associated with the first housing; a second housing within whichthe first housing is encased; an injection member associated with alower portion of the first housing and movable through an injectionopening in the first housing; a spring disposed between the firsthousing and the second housing; at least one detection elementassociated with the container and provide an output based on a conditiondetected by the at least one detection element; an actuation mechanismassociated with the system such that when the actuation mechanism isactivated, the first housing moves relative to the second housing in afirst direction, the spring is biased, the injection member is extendedfrom the second housing, the stopper moves relative to the first housingto deliver medicament through the injection member, such that when thefirst housing moves relative to the second housing in a seconddirection, the spring is released and the injection member is retractedinto the second housing to prevent an unintentional contact with theinjection member; wherein in a first mode of operation of the system,the medicament is delivered through the injection member and in a secondmode of operation of the system, the medicament is not delivered throughthe injection member, and the mode of operation is dependent on theoutput generated by the at least one detection element.
 42. The systemof claim 41, wherein in the first mode of operation, the actuationmechanism is activated and medicament is delivered through the injectionmember and in the second mode of operation, the actuation mechanism isinactivated and medicament delivery through the injection member ishalted.
 43. The medicament delivery system of claim 42, whereinfollowing the second mode of operation of the system, the system isreset such that any remaining medicament in the container can bedelivered through the injection member. 44-45. (canceled)
 46. Themedicament delivery system of claim 41, wherein the at least onedetection element comprises a contact sensor, wherein the outputprovided by the at least one detection element is dependent on whether acontact is made between the contact sensor and a patient.
 47. Themedicament delivery system of claim 41, wherein the at least onedetection element comprises a light sensor, and the output is dependenton whether a light beam is projected from the container.
 48. Themedicament delivery system of claim 41, wherein the at least onedetection element comprises a temperature sensor, and the output of theat least one detection element is dependent on a temperature of a skinof the patient detected by the temperature sensor. 49-66. (canceled) 67.The medicament delivery system of claim 41, wherein the system furthercomprises a flow sensor to detect the amount of medicament deliveredthrough the injection member, wherein based on the amount of medicamentdetected by the flow sensor, an amount of medicament remaining in thecontainer can be identified.
 68. (canceled)
 69. The medicament deliverysystem of claim 64 wherein following the second mode of operation, thesystem is configured for reset, wherein the container can be replaced.70. The medicament delivery system of claim 69, wherein when thecontainer is replaced, the system is reset to begin the first mode ofoperation upon activation of the actuation mechanism.
 71. The medicamentdelivery system of claim 41 further comprising a stopping mechanism,wherein the stopping mechanism is activated in response to an outputgenerated by the at least one detection element, wherein the stoppingmechanism is configured to halt delivery of the medicament after theactuation mechanism has been activated.
 72. The medicament deliverysystem of claim 71, wherein the stopping mechanism is activated inresponse to an output generated by the at least one detection elementand at least a first sensing element, wherein the stopping mechanism isconfigured to halt delivery of the medicament after the actuationmechanism has been activated. 73-93. (canceled)
 94. A method ofdetecting a wet injection during a patient injection in a medicamentdelivery system comprising an injection member and a first containercontaining a medicament dose, said method comprising: sensing an amountof medicament in the container and/or an amount of medicament deliveredthrough the injection member to detect an incomplete delivery ofmedicament; detecting a condition of the system during a patientinjection, wherein a removal of the injection member from the patientduring the patient injection is detected.
 95. The method of claim 94,further comprising storing the condition detected.
 96. The method ofclaim 94, further comprising generating an output based on the conditiondetected.
 97. The method of claim 94, further comprising preventingfurther delivery of medicament through the injection member when removalof the injection member from the patient is detected and an incompletedelivery of medicament is sensed.
 98. The method of claim 97, furthercomprising providing an indication to the patient to rehabilitate thesystem to complete the medicament dose.
 99. The method of claim 98,further comprising an indication to the patient to replace the firstcontainer with a second container and activate the system to inject acalculated medicament dose amount substantially equivalent to themedicament dose remaining in the first container.
 100. The method ofclaim 98, further comprising providing an indication to the patient tore-insert the injection member into the patient and activate the systemto complete the medicament dose remaining in the container.
 101. Themethod of claim 98, further comprising providing an indication to thepatient to replace the injection member with an unused injection memberand activate the system to complete the medicament dose remaining in thecontainer.